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Clinical Trials/NCT05941104
NCT05941104
Not Yet Recruiting
N/A

The Effect of Frailty on Blood Biology Indicators, Quality of Life and Survival of Patients With Radical Prostatectomy

Anhui Provincial Hospital0 sites100 target enrollmentJuly 15, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prostatic Neoplasms
Sponsor
Anhui Provincial Hospital
Enrollment
100
Primary Endpoint
Change of Quality of Life from baseline(Quality of Life is a generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease.)
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The goal of this observational study is to evaluate the effect of frailty on blood biology indicators, quality of life and survival of patients with radical prostatectomy.

The main questions it aims to answer are:

  1. Evaluate the impact of frailty on the blood biological indicators, quality of life and survival of patients with radical prostatectomy, specifically.
  2. Describe the longitudinal changes in the quality of life of patients with radical prostatectomy.

Participants will be divided into frail group or non-frail group based on frailty assessment. Researchers will compare the two groups to see the impact of frailty on the blood biological indicators, quality of life and survival.

Registry
clinicaltrials.gov
Start Date
July 15, 2023
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
Anhui Provincial Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer (be diagnosed by relevant imaging examinations or pathology);
  • Radical prostatectomy is planned;
  • Voluntarily sign the informed consent form.

Exclusion Criteria

  • Diagnosed with other malignant tumors at the same time;
  • Patients with acute infection.

Outcomes

Primary Outcomes

Change of Quality of Life from baseline(Quality of Life is a generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease.)

Time Frame: baseline(date of hospitalization); 1 month after operation; 3 months after operation; 6 months after operation; 1 year after operation; 2 years after operation.

Quality of life will be measured by the Extended Prostate Cancer Composite Index Scale (EPIC-26). EPIC-26 is used to assess the functional status of patients with prostate cancer in various domains over the past 4 weeks. Be si de s, EPIC-26 is used to describe the extent of its affects in life of patients with prostate cancer. EPIC-26 contains 26 items in five areas, including urinary incontinence, urinary tract irritation, defecation function, sexual function, and endocrine disorders. Cronbach α coefficient of the scale was 0.854. The overall score is 100 points, and the lower score means better quality of life.

Secondary Outcomes

  • Blood Biology Indicators(including IL-2, IL-6, IL-8,TNF-α, PSA and et al)(baseline(date of hospitalization); 1 month after operation; 3 months after operation; 6 months after operation; 1 year after operation; 2 years after operation.)

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